Certificate Course in
Pharmacometrics
Conducted by
SOPHAS
Duration
Total Duration: 16 months (Coursework: 12 months + Project Work: 4 months)
Teaching Methodology
Flipped Classroom approach
Target Audience
Students and professionals interested in working in pharmacokinetics, modeling, or pharmacometrics.
About the program
The Pharmacometrics Certificate Course is SOPHAS’ flagship professional training program, designed to equip participants with the quantitative skills and practical expertise required for modern drug development. Combining a strong foundation in pharmacokinetics, pharmacodynamics, statistics, and model-informed drug development with hands-on training using industry-standard tools, the program bridges theory and real-world application. Through structured learning, practical projects, and expert guidance, participants gain the confidence to apply pharmacometric principles across drug discovery, clinical development, and regulatory decision-making.
Objectives
01
Understand the principles of statistics, pharmacokinetics, and modeling in pharmacometrics.
02
Use quantitative tools for decision-making in drug development and clinical practice.
03
Execute professionally relevant projects with hands-on experience.
Course Structure
A comprehensive 5-phase journey combining theory, practical modeling and project work.
Block 1
Statistics for Pharmacometrics
- 14 weeks
- Online, self-paced with guided materials and live classes
This phase focuses on building a strong foundational understanding through structured self-paced learning.
Participants will :
- Develop a strong foundation in descriptive and inferential statistics, probability, and statistical distributions for pharmacometric analyses.
- Apply hypothesis testing, confidence intervals, power analysis, and sample size estimation to support evidence-based decision-making.
- Use statistical techniques such as ANOVA, correlation, and regression to analyze and interpret biomedical and clinical data.
- Understand the principles of randomization, study design, and statistical methodologies used in clinical trials.
- Build the quantitative skills required to evaluate data, interpret results, and contribute to informed drug development and clinical research decisions.
- Assignments and exercises designed to reinforce core concepts and prepare participants for advanced, hands-on work in later phases
By the end of this phase, learners will be well-equipped with the theoretical background and tools needed for the application-oriented stages of the program.
Block 2
Basics of Pharmacokinetics
- 14 weeks
- Online, self-paced with guided materials.
Participants will learn to:
- Understand the fundamental principles of Absorption, Distribution, Metabolism, and Excretion (ADME) and their role in determining drug disposition.
- Develop and apply compartmental pharmacokinetic models to describe and predict drug concentration–time profiles.
- Analyze pharmacokinetic behavior following intravenous bolus, oral absorption, and elimination processes.
- Evaluate multiple dosing regimens, steady-state pharmacokinetics, and drug accumulation to support dosage optimization.
- Apply pharmacokinetic principles to interpret clinical data and inform drug development and therapeutic decision-making.
Block 3
Basics of Modelling
- 14 weeks
- Online, self-paced with guided materials.
Participants will learn to:
- Develop pharmacometric models through hands-on, project-based learning using real-world datasets and industry-relevant workflows.
- Build and evaluate structural pharmacokinetic and pharmacodynamic models to characterize drug behavior and response.
- Incorporate covariate analysis and quantify inter-individual variability to improve model performance and predictive accuracy.
- Apply mechanistic modeling approaches to better understand biological systems and drug action.
- Use simulation techniques to support dose optimization, clinical trial design, and model-informed drug development decisions.
Block 4
Final Capstone Project
- 20 weeks
- Online, self-paced with guided materials.
Participants will learn to:
- Apply pharmacometric concepts to solve real-world drug development challenges using industry-relevant datasets.
- Design and execute complete pharmacometric modeling workflows from data preparation to model evaluation.
- Analyze and interpret modeling results to support informed decision-making in drug development.
- Gain hands-on experience with professional pharmacometric software and best practices used in the industry.
- Develop and present project outcomes through technical reports and presentations, demonstrating job-ready modeling skills.
Submission and Certification
- 1 month
In the final phase of the program, learners will complete their learning journey through project submissions and final assessments.
This phase concludes the program, recognizing participants based on their engagement and performance:
- Certificate of Attendance: For those who complete the virtual learning and attend the in-person workshop.
- Certificate of Completion: For those who submit the capstone project and meet performance criteria. Certificates will be given during the ICoP India conference.
These certificates formally acknowledge the participant’s proficiency in leveraging artificial intelligence techniques to advance drug development processes and make data-driven decisions.
Topics to be Covered:
Covers the foundational concepts of biopharmaceutics and pharmacokinetics, including physicochemical properties, anatomy and physiology, and formulation development. It also introduces in vitro method development and regulatory expectations for dissolution and biowaivers.
Focuses on applying fundamentals to develop bio-indicative dissolution methods for solid and complex dosage forms. It also addresses biowaivers, SUPAC changes, and regulatory aspects of dissolution specifications and similarity. Plan to cover in depth about dissolution evaluation from biopharmaceutics and biopredictivity perspectives.
Provides core understanding of pharmacokinetics, including ADME processes, modeling approaches, and enzyme/transporter effects. It also introduces bioequivalence concepts and global regulatory requirements. Along with USFDA, EMA, harmonized ICH guidance and other specific agency requirements may also be covered.
Emphasizes advanced applications such as BE data analysis, IVIVC development, and PBPK modeling. It also covers virtual bioequivalence, food effects, and critical bioavailability considerations. Few aspects on 505b(2) may also be covered.
Involves practical learning through case study discussions integrating earlier modules. Concludes with capstone project presentations to apply and demonstrate overall understanding.
Instructors
Dr Yoni Nazarathy
Associate Professor at The University of Queensland | Consultant at Accumulation Point
Dr Vijay Ivaturi
Co-Founder & CEO Pumas-AI, & Endowed Chair - Center for Pharmacometrics at Manipal, Past-President ISoP
Course Coordinators
Dr Surulivel Rajan M
SOPHAS President
Mr Leroy Alvares
SOPHAS Team
|
Category
|
INR (₹) Fee
|
|---|---|
|
Students/Trainees
|
₹1,50,000
|
|
Academics
|
₹2,00,000
|
|
Industry
|
₹4,00,000
|
Account Name: EVINAHTA CONSULTANCY PRIVATE LIMITED
Account Number: 007205002908
Account Type: Current
IFSC Code: ICIC0000072
Branch: Manipal, Karnataka
*In the Add Note section, please add Full name & Institution/Industry Name & City
OR
Pay via our Razorpay link: https://rzp.io/rzp/biopharm
NOTE: Please fill the registration form once the payment has been done.
Registration for this batch has now closed.
Thank you for your interest! This batch is now full and registrations have now ended. Please keep a eye on our website and LinkedIn page for announcements about upcoming batches and future enrollment and opportunities.
Registration Form
For group registrations & fee related queries, reach out to us at connect@sophas.net and unlock a smoother, faster onboarding experience.
Upon completing the payment, please ensure you upload the payment proof and enter the Transaction ID in the registration form, along with the other required information.